Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
- Conditions
- Acute Lymphoblastic LeukemiaPhiladelphia Chromosome
- Interventions
- Drug: Standard chemotherapy + Imatinib
- Registration Number
- NCT00287105
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.
- Detailed Description
Recent advances in treatment have increased the cure of childhood ALL to 75% or better. However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have been largely unsuccessful. Imatinib, an inhibitor of protein-tyrosine kinases, is currently being tested in several phase I, II and III trials covering most Chronic Myeloid Leukemia patient populations and patients with overtly relapsed or refractory Ph+ALL. Pediatric patients with Ph+ALL will receive Imatinib, added to intensive, post-induction BFM-type chemotherapy. The endpoint will be the evaluation on the long-term clinical outcome, in particular on the Disease Free Survival (DFS).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Children and adolescents aged 1 to 17 years at diagnostic
- Documented Ph+ ALL
- Eligibility for the current local prospective therapeutic study of childhood ALL
- Informed consent given by the parents or by legal guardian
- Abnormal hepatic functions
- Abnormal renal functions
- Active systemic bacterial, fungal or viral infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Good risk Ph+ALL Standard chemotherapy + Imatinib For protocols which adopt a steroid prephase: patients who are Prednisone-good responder and achieve CR after the induction course. For protocols which do not adopt steroid prephase: patients who have M1/M2 BM at day 15 or M1 BM at day 21 and achieve CR after the induction course. Expected stratification in this group: 70-75%. Poor risk Ph+ALL Standard chemotherapy + Imatinib For protocols which adopt a steroid prephase: patients who are Prednisone poor-responders. For protocol which do not adopt a steroid prephase: patients who have M3 BM at day 15 or M2/M3 BM at day 21. For all protocols: patients who do not achieve CR after the induction course. Expected stratification: 25-30%.
- Primary Outcome Measures
Name Time Method Disease free survival (DFS). DFS will be calculated as the time from inclusion to either one of the following events: relapse, death in CCR, second malignancies. 2 years
- Secondary Outcome Measures
Name Time Method Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA). 2 years Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. 2 years Pattern of molecular response (MRD) 5 time points between S4 and S22 Conversion rate to CR in patients resistant to the first part of the induction phase of chemotherapy included in the Poor-risk group. 2 years
Trial Locations
- Locations (22)
Service d'hémato-oncologie - Hôpital des Enfants Pellegrin
🇫🇷Bordeaux, France
Limoges University Hospital
🇫🇷Limoges, France
Service hématologie pédiatrique Hôpital Saint-Jacques
🇫🇷Besancon, France
Hôpital Morvan
🇫🇷Brest, France
Pédiatrie CHU - Hôpital Nord
🇫🇷Grenoble, France
Hôpital Jeanne de Flandre
🇫🇷Lille, France
Hématologie pédiatrique-Hopital américain
🇫🇷Reims, France
Hématologie oncologie pédiatrique-CHU Caen
🇫🇷Caen, France
Hématologie Hôpital Jean Bernard
🇫🇷Poitiers, France
Service d'hématologie pédiatrique - Hôpital Sud
🇫🇷Rennes, France
Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle
🇫🇷Rouen, France
Hôpital d'enfants
🇫🇷Vandoeuvre Les Nancy, France
Hémato-Oncologie Pédiatrique - Hôpital d'Enfants
🇫🇷Dijon, France
Hopital des enfants
🇫🇷Toulouse, France
Hématologie Pédiatrique - Hôpital Trousseau
🇫🇷Paris, France
Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique
🇫🇷Lyon, France
Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu
🇫🇷Clermont-Ferrand, France
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
CHU- Centre Gatien de Clocheville
🇫🇷Tours, France
Service d'hématologie pédiatrique CHRU
🇫🇷Amiens, France
Hématologie, Oncologie pédiatrique-CHU Saint Etienne
🇫🇷Saint Etienne, France
Hémato-immunologie-Robert Debré
🇫🇷Paris, France